MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-03-13 for OPMI LUMERA 700 305953-9900-000 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[102343602]
Manufacturer tried to contact the customer to get access to the microscope for evaluation. So far, the manufacturer has been unsuccessful in getting access to the microscope. Manufacturer's records confirm that device training was provided to the surgeon and hospital personnel on 02/19/2018.
Patient Sequence No: 1, Text Type: N, H10
[102343603]
A health care professional (hcp) reported that the retro-illumination of the opmi lumera 700 microscope stopped working during a surgery. The outcome of the patient is unknown to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2018-00004 |
| MDR Report Key | 7335926 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-13 |
| Date of Report | 2018-02-13 |
| Date of Event | 2018-02-13 |
| Date Mfgr Received | 2018-02-13 |
| Device Manufacturer Date | 2012-09-20 |
| Date Added to Maude | 2018-03-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. WILLIAM GUSTAFSON |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574689 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG (OBERKOCHEN) |
| Manufacturer Street | RUDOLF-EBER-STRASSE 11 |
| Manufacturer City | OBERKOCHEN, BADEN-WUERTTEMBERG 73447 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 73447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPMI LUMERA 700 |
| Generic Name | LUMERA 700, |
| Product Code | HRM |
| Date Received | 2018-03-13 |
| Model Number | NA |
| Catalog Number | 305953-9900-000 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG (OBERKOCHEN) |
| Manufacturer Address | RUDOLF-EBER-STRASSE 11 OBERKOCHEN, BADEN-WUERTTEMBERG 73447 GM 73447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-13 |